Topic : Sterile Filtration of Pharmaceutical Products – Validation and Regulatory Requirements

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Overview

Sterile filtration is one of the most critical steps in sterile pharmaceutical manufacture. This is because the filtration process provides the assurance of sterility in the finished drug product.

Therefore, the design, validation and ongoing monitoring of a sterile filtration system are essential for assuring the quality and safety of the pharmaceutical product.

Proper understanding and testing of the sterile filtration system according to international regulatory standards is essential for both the validation and ongoing monitoring of the system.

Areas Covered in the Session :

  • Sterile filtration – Importance of Quality
  • Sterility Assurance of Sterile Filtration
  • Sterile Filtration System Design
  • Discussion of Different Filtration Media Properties and Retention Mechanisms
  • Methods for Sterilization of Filters
  • Validation of Sterile Filter Systems
  • Microbial Retention Challenge Testing
  • Integrity Testing
  • Product Compatibility Testing
  • Extractable/Leachable Testing
  • Regulatory Requirements

Speaker Profile :

Roger Cowan is the Keynote Spaker at ComplianceKey. He is the founder and owner of R Cowan Consulting Services LLC, a consulting company specializing primarily in the area of pharmaceutical contract manufacturing. He has 35 years experience in pharmaceutical quality assurance and manufacturing. In his career, Roger has held various manager / director positions in Quality Assurance, QC Laboratory, Technical Services Validation, Manufacturing, and Clinical Supply manufacturing and distribution. Roger has taught courses in microbiology at Seneca College (Pharmaceutical Technology Program) in Toronto, Canada.

Contact Info :

Compliance Key

https://www.compliancekey.us

Email : support@compliancekey.us

Phone : +1 717-208-8666

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